Adherence to Activity Limitations in Diabetes

NCT03853941 | Completed

• 1 other identifier: 18033
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.

Conditions

Diabetes; Foot Ulcer

Keywords

Motivation; Communication; Healthcare Professional; Training; Adherence; Diabetes; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Change in healthcare professionals' communication style

  Measured using the 6-item Health Care Climate Questionnaire, and indicated by patients' perceptions of healthcare professional autonomy support being higher in the intervention group compared to the control group.

  Baseline

Secondary Outcomes (4)

• Change in patients' adherence to activity reduction recommendations

  1 month

• Change in patient treatment self-regulation

  Baseline

• Acceptability of the intervention

  Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline

• Fidelity of delivery

  Baseline

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will receive treatment as usual.

Experimental

EXPERIMENTAL

The experimental group will receive clinical treatment as usual, however, the healthcare professionals treating them will have received training on how to enhance patient adherence via the use of a motivationally supportive communication style. Thus, the style/language healthcare professionals use to convey usual treatment recommendations may differ.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Theory-based communication training programme delivered to healthcare professionals

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 18 years and over
• Have diabetes according to WHO criteria
• Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital
• Be able to communicate and complete questionnaire measures in English
• Have capacity to consent and agree to participate.

You may not qualify if:

• \- Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Communication

Interventions

Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jennie Hancox, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 26, 2019
• Study Start: March 21, 2019
• Primary Completion: February 14, 2020
• Study Completion: September 10, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)